a) Field of the Invention
This invention relates to the collection of urine specimens and other body fluids from patient groups including adult females, adult males, and pediatric males.
b) Discussion of the Prior Art
Medical science has proven the need for routine urinalyses to detect enumerable disease processes. The most commonly used method for this in the hospital, office practice, home health practice and nursing homes, is a clean catch mid-stream urinalysis. The clean catch mid-stream urinalysis is currently collected in one of many different size cups or containers. However, it has been found that adult females, adult uncircumcised males, and pediatric males have specific and distinct problems in relation to the presently used collection methods. For example, in the adult female, vaginal voiding and contamination by the labia and hair of the vaginal region during the act of micturition renders many of the urinalyses unusable in relation to accurate bacterial red blood cell, leucocyte, and nitrite quantifications. In present practice in order to circumvent this potential contamination the insertion of a tube into the bladder is needed for an accurate urinalysis when looking for an infection. In the adult uncircumcised male, for example, often this person is not instructed in the proper collection of the specimen (pulling the foreskin back and cleansing the glans penis) and therefore contamination occurs when he urinates through the foreskin into the collection device. Also, for example, in the neonatal and young pediatric male, collection devices are generally a bag-like device placed around the scrotum, penis, and suprapubic region, which severely enhances bacterial contamination. Even further, in cases where a patient needs catheterization because a fluid specimen is inaccurate, it has been found that catheterization leads to infection in twenty percent of the patients who are catheterized. Thus, the need for a device for fluid sampling other than catheterized specimens is needed. Additionally the cup containers frequently are spilled in transit to the lab when caps are not screwed on containers properly. This requires recollection of specimens and is very time consuming and cost inefficient.
Moreover, medical science has proved the need for collection of sputum samples for analysis in relation to infections and detection of cancers and viruses as well as for drug testing. In the use of cup containers, the caps for the cups become unscrewed or the caps are not placed correctly on the cups and the specimens spill out. This necessitates re-collection of the specimen which is time consuming and expensive for the patients and the hospitals.
Furthermore, medical science has proven the need for collection of semen analyses for evaluation of patients with infertility and to assess post vasectomy patients. Presently, patients collect specimens for these analyses in baggies, condoms, jars, and cups which have proved to be difficult for physicians and lab personnel to work with.
There have been a number of suggestions for apparatuses for taking urinary samples in the prior art, but none have found acceptability in the medical profession involved with overseeing the taking of samples and transporting said samples for analytical evaluation. One particular reference noted is U.S. Pat. No. 26,854 which teaches an apparatus for collecting urine samples from female patients which includes a container with an elongated tube sealingly mounted in the open end of the container. The elongated tube on its distal end includes a compressible and resilient pad portion which is adapted to be positioned around the urethral meatus and in use the urine is collected in the sample collector.